Protocol summary
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Study aim
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Determining the effect of couples relationship enhancement counseling program on sexual function, sexual life quality and sexual satisfaction in women with type 2 diabetes
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Design
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Clinical trial with parallel groups, randomized on 23 couples. Simple randomization method is used for randomization.
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Settings and conduct
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1- Location of the study: Mehrgan diabetes association center of Qom and Seyyed al-Shohda Clinic (Shahid Hinduyan) are the research environment of this study. 2- The study population: Women with type 2 diabetes. 3- Type of blinding: due to the nature of the study, there is no possibility of blinding and only blinding of the statistician will be done.
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Participants/Inclusion and exclusion criteria
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23 couples in which only the woman has diabetes with the age range of 35 to 55 years will be included in the study, and women with psychiatric disorders and other chronic diseases will be excluded from the study.
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Intervention groups
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The first group (intervention) will be assigned to the group receiving couples relationship enhancement counseling and the second group (control) will be assigned to the group receiving regular programs.
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Main outcome variables
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Sexual function; sexual life quality; sexual satisfaction
General information
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Reason for update
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The word 'program' was missing in the title, and the word 'counseling' was translated as 'training' in English. Therefore, the title has been revised accordingly.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20240415061491N1
Registration date:
2024-05-10, 1403/02/21
Registration timing:
prospective
Last update:
2025-02-12, 1403/11/24
Update count:
1
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Registration date
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2024-05-10, 1403/02/21
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-05-21, 1403/03/01
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Expected recruitment end date
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2024-10-21, 1403/07/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of couples relationship enhancement counseling program on sexual function, sexual life quality and sexual satisfaction in women with type 2 diabetes
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Public title
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Effect of couples relationship enhancement counseling program on sexual function, sexual life quality and sexual satisfaction in women with type 2 diabetes
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
35 to 55 years old
Being married and having a sexual partner
Being literate in reading and writing
At least one year has passed since their illness and they have laboratory criteria with FBS ≥ 126 or HbA1C ≥ 6.5
Good blood sugar control status (average FBS ≤ 130 mg/dL in the last three months)
Having sexual activity during the last 6 months or at least six months of cohabitation
People who answered positively to at least one of the questions in the sex screening form
Exclusion criteria:
Attending another study at the same time
History of participating in psychological training classes aimed at improving sexual problems
History of psychiatric disorders
Experiencing recent crises in life
Using any type of sedative, alcohol and drugs in couples
History of severe marital disputes and going to court
Breastfeeding
Menopause
History of mastectomy or complete hysterectomy
History of psychiatric disorders
Suffering from other acute or chronic diseases in couples (blood pressure, heart, kidney, liver and thyroid diseases)
Use of oral contraceptives and corticosteroids
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Age
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From 35 years old to 55 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
46
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Individuals will be randomly assigned to one of two study groups with the help of a random number table and will receive the intervention of the allocated group. For allocation concealment, the method of sealed opaque envelopes which are numbered sequentially will be used. In this method, each random sequence is recorded on a card. Finally, the lids of the letter envelopes will be glued and placed inside a box. At the beginning of the study, according to the order of entry of eligible participants to study, one of the envelopes will be opened in order and the assigned group of the participant will be revealed.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2024-04-15, 1403/01/27
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Ethics committee reference number
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IR.MUQ.REC.1403.010
Health conditions studied
1
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Description of health condition studied
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Diabetes
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ICD-10 code
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E08
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ICD-10 code description
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Diabetes mellitus due to underlying condition
Primary outcomes
1
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Description
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Quality of sexual life
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Timepoint
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Before, 2 weeks and 12 weeks after participating in the meetings in two intervention and control groups
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Method of measurement
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Women's sexual life quality questionnaire
2
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Description
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Sexual satisfaction
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Timepoint
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Before, 2 weeks and 12 weeks after participating in the meetings in two intervention and control groups
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Method of measurement
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Larson's sexual satisfaction questionnaire
3
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Description
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Sexual performance
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Timepoint
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Before, 2 weeks and 12 weeks after participating in the meetings in two intervention and control groups
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Method of measurement
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Women's sexual performance scale
Intervention groups
1
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Description
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Intervention group: Couples relationship enrichment intervention will take place during six 90-minute sessions. The executive protocol of marital relationship enrichment sessions (RET) will be conducted in the form of couple counseling and in the presence of husband and wife, and the enrichment package will be based on similar interventions taken from two treatment books based on communication enrichment and the book of sex education sessions taken from my wife's book with comments from Specialists will be specially designed.
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Category
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Lifestyle
2
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Description
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Control group: The control group receives only the usual treatments.
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Category
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Lifestyle
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Ghoum University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Still undecided - no release schedule yet
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When the data will become available and for how long
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Still undecided - no release schedule yet
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To whom data/document is available
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People working in scientific and research institutions
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Under which criteria data/document could be used
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If all group members agree, the file can be accessed.
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From where data/document is obtainable
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Dr Zohre Khalajinia
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What processes are involved for a request to access data/document
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The applicant should send an email to Dr. Khaljinia. It will be sent if agreed.
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Comments
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